Progressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-22

Study Completion Date

2026-02-28

Brief Summary

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This is a multi-center, randomized, double-masked clinical trial. All study devices are market approved/cleared in the localities where the study is conducted. Subjects will be randomly assigned to wear NaturalVue Sphere single vision contact lenses (SVCL) or NaturalVue Multifocal (NVMF) soft contact lenses for a total of three years.

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Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control

Contact lens with refractive correction, single vision optic

Group Type PLACEBO_COMPARATOR

Single vision contact lenses

Intervention Type DEVICE

Wearing contact lenses during waking hours may alter the progression of myopia

Treatment

Contact lens with refractive correction, multifocal optic

Group Type EXPERIMENTAL

Multifocal contact lenses

Intervention Type DEVICE

Wearing contact lenses during waking hours may alter the progression of myopia

Interventions

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Single vision contact lenses

Wearing contact lenses during waking hours may alter the progression of myopia

Intervention Type DEVICE

Multifocal contact lenses

Wearing contact lenses during waking hours may alter the progression of myopia

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Male or female, aged 7 to \<13 (inclusive) at the Screening/Baseline examination.
2. Meet the following refractive criteria determined by cycloplegic autorefraction at Screening/Baseline:

* Spherical Equivalent Refractive Error (SERE): between -0.75 and -5.00 D inclusive.
* Astigmatism: ≤ -0.75 D
* Anisometropia: \< 1.000

Exclusion Criteria

1. Has previously worn or currently wears rigid or gas permeable contact lenses, including orthokeratology lenses,
2. Appears to exhibit poor personal hygiene, that, in the Investigator's opinion, might prevent safe contact lens wear.
3. Is currently, or within 30 days prior to this study has been, an active participant in another clinical study.
4. Current or prior use of bifocals, progressive addition lenses, atropine, pirenzepine, multifocal or specialized contact lenses, or ANY other myopia control treatment.
5. The Investigator for any reason considers that it is not in the best interest of the subject to participate in the study, including if the child is not mature enough to independently handle and care for soft contact lenses.

Minimum Eligible Age

7 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes